KR20230175324A - Simulated tissue models and methods - Google Patents

Abstract

Simulated tissue constructs for practicing surgical techniques and methods of manufacturing such constructs are provided. In particular, a realistic organ model or simulated tissue section is provided for practicing the removal of a tumor or other undesirable tissue followed by suturing the remaining defect as part of the same surgical procedure. Simulated tissue constructs include a polyp simulation with a mesh layer that is separable from the defective layer and capable of being sutured. A fully suturable rectal model and a rectal model with suturable and removable polyp zones are also provided, as well as a simulated colon model with interchangeable and resealable tissue pods.

Description

SIMULATED TISSUE MODELS AND METHODS}

Cross-reference to related applications

This application claims priority and the benefit of U.S. Provisional Patent Application Serial No. 62/089,919, filed December 10, 2014, entitled “Suturable rectum model,” which is incorporated herein by reference in its entirety; This application claims priority and the benefit of U.S. Provisional Patent Application Serial No. 62/079,523, filed November 13, 2014, entitled “Fully suturable rectum,” which is incorporated herein by reference in its entirety; This application claims priority and the benefit of U.S. Provisional Patent Application Serial No. 62/079,479, filed November 13, 2014, entitled “One piece polyp simulation,” which is incorporated herein by reference in its entirety; This application claims the priority and benefit of U.S. Provisional Patent Application Serial No. 62/118,179, filed February 19, 2015, entitled “Method of making simulated tissue using stencils,” which is hereby incorporated by reference in its entirety. insist.

Technology field

This application relates generally to surgical training tools, and more specifically to anatomical models that simulate organs or tissues for teaching and practicing various surgical techniques and procedures.

Medical students, as well as experienced doctors learning new surgical techniques, must undergo intensive training before they are qualified to perform surgery on human patients. Training should teach appropriate techniques for using a variety of medical devices to cut, drill, clamp, grasp, staple, and suture various tissue types. The range of possibilities that a trainee can face is very large. For example, different organs and patient anatomies and diseases are presented. The thickness and hardness of the various tissue layers will also vary from part to part of the body and from patient to patient. Accordingly, the required skills of technologies and instruments will also change. Additionally, trainees must practice techniques in easily accessible open surgical positions and in laparoscopically accessed positions.

Numerous teaching aids, trainers, simulators and model organs are available for one or more aspects of surgical training. However, a need exists for model organs or simulated tissue elements likely to be encountered in endoscopic, laparoscopic, transanal, minimally invasive or other surgical procedures involving the removal of tumors or other tissue structures. In particular, there is a need for realistic model organs for the repeatable practice of removing tumors or other unwanted tissue, followed by closure of the target area by suturing or stapling as part of the same surgical procedure. In view of the above, it is an object of the present invention to provide a surgical training device that realistically simulates these specific situations encountered during surgery.

According to one aspect of the invention, a simulated tissue construct for surgical training is provided. The structure includes a first layer made of silicone having a first substantially flat surface opposed to a second substantially flat surface defining a first thickness therebetween. The first layer has protrusions extending outwardly from the first surface at an outer periphery and protruding locations within the outer periphery. The first thickness is substantially uniform and the protrusion is defined by the increased first thickness of the first layer. The structure includes a second layer made of silicone having a substantially flat second surface opposed to a substantially flat second surface defining a second thickness therebetween. The second thickness is substantially uniform. The second layer has an outer periphery, wherein the outer periphery of the first layer and the outer periphery of the second layer are aligned, and on the first layer such that the first surface of the second layer is facing and contacting the second surface of the first layer. connected. The first and second layers are bonded together with an adhesive positioned around the protrusion location such that the first layer and the second layer are releasable at the protrusion location to facilitate resection of the protrusion.

According to another aspect of the invention, a simulated tissue construct for surgical training is provided. The simulated tissue construct includes a substantially cylindrical tube with side walls having an interior surface and an exterior surface extending between a proximal end and a distal end and defining a central lumen having a longitudinal axis. At least one of the proximal end and the distal end is open. The cylindrical tube includes at least one opening extending across the side wall from the interior surface to the exterior surface. The structure includes at least one pod configured and sized for insertion into at least one opening. The pod is also configured for a removable connection with a cylindrical tube. The pod contains a cap and simulated tissue connected to the cap. The cap has a flange and includes a frame defining an opening. The simulated tissue includes at least one smooth layer of silicone having an inner surface and an outer surface. The simulated tissue is connected to the flange such that the outer surface of the simulated tissue is connected to the flange and the simulated tissue spans the opening defined by the frame. The pod is removably connected to the cylindrical tube such that the simulated tissue is aligned with the inner surface of the side wall when connected to the cylindrical tube.

According to another aspect of the invention, a method for manufacturing a simulated tissue model is provided. The model includes providing an elongated mandrel with an outer surface having at least one depression, rotating the mandrel, and applying a first layer of uncured silicone onto the mandrel. and allowing the first layer to cure to form a substantially tubular structure having an interior surface and an exterior surface and a well having a depth formed within the exterior surface at the location of the depression. The method includes providing a second layer of cured silicone having a shape substantially corresponding to the shape of the well and a thickness substantially corresponding to the depth of the well, positioning the second layer within the well of the first layer. , applying a third layer of uncured silicone on the exterior surfaces of the first and second layers, and allowing the third layer to cure and adhere to the first and second layers to form a smooth exterior surface. Includes more steps. The method further includes providing a simulated tumor having a smaller size than the second layer, and attaching the simulated tumor to the interior surface of the first layer at a location of a depression adjacent the second layer.

According to another aspect of the invention, a method for manufacturing a simulated tissue model is provided. The method includes providing an elongated mandrel having an outer surface, applying a first layer of uncured silicone onto the mandrel, the first layer forming a substantially tubular structure having an inner surface and an outer surface. It includes a step of allowing it to harden. The method further includes providing a simulated tumor having a smaller size than the first layer, and attaching the simulated tumor to a location on the interior surface of the first layer. The method further comprises providing a second layer of cured silicone having a size greater than the size of the tumor, positioning the second layer on the outer surface of the first layer at a location opposite the location of the tumor. do.

According to another aspect of the invention, a method for manufacturing a simulated tissue model is provided. The model includes providing an elongated mandrel with an outer surface provided with at least one outward detent, rotating the mandrel, and applying a first layer of uncured silicone onto the mandrel. and allowing the first layer to cure to form a substantially tubular structure defining a lumen and an outer surface and a well having a depth formed within the inner surface at the location of the outward detent. The method further includes providing a polyp simulation and positioning the polyp simulation within a well of the first layer.

Figure 1 illustrates a side view of a surgical training device with a model organ according to the invention.
Figure 2A illustrates a side cross-sectional view of a simulated tissue construct according to the present invention.
Figure 2b illustrates a side cross-sectional view of a simulated tissue construct with a resected tumor according to the present invention.
Figure 2C illustrates a side cross-sectional view of a simulated tissue construct with the sutures open according to the present invention.
Figure 2D illustrates a side cross-sectional view of a simulated tissue construct with the sutures closed according to the present invention.
Figure 3a illustrates a top view of a defect layer with circular defects according to the invention.
Figure 3b illustrates a top view of a defect layer with elongated defects according to the present invention.
Figure 3c illustrates a top view of a defective layer with irregular defects according to the present invention.
3D illustrates a top view of a defect layer with a two-piece defect according to the present invention.
Figure 3e illustrates a top view of a multi-part defect layer according to the present invention.
Figure 3f illustrates a top view of a defect layer with a plurality of defects according to the present invention.
Figure 4 illustrates a top view of a simulated tissue construct according to the present invention.
Figure 5 illustrates a side cross-sectional view of a simulated tissue construct according to the present invention.
Figure 6a illustrates a perspective view of a modular tissue structure and support according to the invention.
Figure 6b illustrates a perspective view of a modular tissue structure and support according to the invention.
Figure 7 illustrates a cross-sectional view of a simulated tissue construct configured to mimic a human uterus according to the present invention.
Figure 8 illustrates a top view of a modular tissue structure according to the present invention.
Figure 9 illustrates a top view of a modular tissue structure according to the present invention.
Figure 10A illustrates a perspective view of a simulated tissue construct according to the present invention.
Figure 10b illustrates a perspective view of a simulated tissue construct according to the present invention.
Figure 11A illustrates a perspective view of a simulated tissue construct according to the present invention.
Figure 11B illustrates a perspective view of a simulated tissue construct according to the present invention.
Figure 12 illustrates a perspective view of a suturing needle and simulated tissue construct according to the present invention.
Figure 13a illustrates a transparent side view of a polyp simulation according to the present invention.
Figure 13b illustrates a side elevational view of the defect layer of a polyp simulation according to the present invention.
Figure 13C illustrates a side elevational view of the mesh layer of a polyp simulation according to the present invention.
Figure 13D illustrates a side elevational view of the muscle layer of a polyp simulation according to the present invention.
Figure 14a illustrates a side front view of a mold for a muscle layer according to the invention.
Figure 14b illustrates a top view of a mold for a muscle layer according to the invention.
Figure 15a illustrates a side elevational view of a mold for a defective layer according to the invention.
Figure 15b illustrates a top view of a mold for a defective layer according to the invention.
Figure 16 illustrates an exploded view of the defect mold, defect layer, mesh layer, mold release layer and muscle layer according to the present invention.
Figure 17A illustrates a tissue simulation model with pods with attached simulated tissue portions in accordance with the present invention.
Figure 17b illustrates a pod assembly according to the present invention.
Figure 17C illustrates an exploded view of a pod assembly according to the present invention.
Figure 18 is a bottom perspective view of a pod frame without tissue portions according to the present invention.
Figure 19 is a top perspective cross-sectional view of the tissue simulation module according to the present invention.
Figure 20 is a top perspective view of a portion of a mandrel used to fabricate a tissue simulation model according to the present invention.
Figure 21 is a cross-sectional view of a tissue simulation model according to the present invention.
Figure 22 is a top perspective view of a tissue simulation model according to the present invention.
Figure 23 is a cross-sectional view of a tissue simulation model according to the present invention.
Figure 24 is a cross-sectional view of a mandrel for manufacturing a tissue simulation model according to the present invention.
Figure 25 is a cross-sectional view of a tissue simulation model according to the present invention.
Figure 26A is a top plan view of the mesh layer of a tissue simulation model according to the present invention.
Figure 26b is a top plan view of the mesh layer of a tissue simulation model formed with a cylindrical sleeve according to the present invention.
Figure 27 illustrates a mesh sleeve positioned on a mandrel according to the invention.
Figure 28 illustrates a mesh sleeve positioned on a mandrel according to the invention.
Figure 29 illustrates an end cross-sectional view of a fully suturable rectum with an exemplary suture path according to the present invention.

A surgical training device 10 configured to mimic a patient's torso, such as the abdominal region, is illustrated in FIG. 1 . The surgical training device 10 provides a simulated body cavity 18 that is substantially obscured from the user for receiving simulated or live tissue 20 . The body cavity 18 is accessed through a tissue simulation area 19 penetrated by devices used by the user to practice surgical techniques on tissue or organs 20 located and found within the body cavity 18. Although body cavity 18 is shown as accessible through tissue simulation area 19, U.S. Patent Application Serial No. 19, filed Sep. 29, 2011, entitled “Portable Laparoscopic Trainer,” which is hereby incorporated by reference in its entirety. A hand-assisted access device or single-site port device as described in Ser. No. 13/248,449 may alternatively be used to access body cavity 18. The surgical training device 10 is particularly suitable for practicing laparoscopic or other minimally invasive surgical procedures.

The surgical training device 10 includes a base 12 and a top cover 14 connected to and spaced from the base 12 to define an internal cavity 18 between the top cover 14 and the base 12. do. At least one leg 16 separates the top cover 14 and the base 12 and interconnects them. A model organ or simulated tissue 20 is placed within the body cavity 18 . The model organ 20 shown in FIG. 1 is a partial colon or intestine shown suspended from the top cover 14 by tethers 22 and connected to at least one leg 24 . At least one leg 24 has an opening (not shown) facing the internal cavity 20. Model colon 20 includes a tube 26 having a proximal end and a distal end. The proximal end of tube 26 interconnects with an opening in leg 16 such that the opening provides an access port to the lumen of tube 26. The access port and opening are shown in FIG. 1 closed with an access device 28, which is adapted for infusion with fluid deliverable through the infusion port 30 with a sealed distal end of the tube 26. Model organs (20) are provided. An optional insert 32 made of a soft material such as silicone creates a realistic interface to the access port. The distal end of tube 26 extends into and suspends within body cavity 18 . The interior of the tube 26 of the simulated organ 20 is accessible through an access port in the leg 24 or through the tissue simulation area 19 or instrument insertion ports 34. An endoscopic camera inserted into body cavity 18 or into organ 20 through an access port generates live images for display on folded video screen 36, shown in a closed position in Figure 1. Although the simulated organ 20 of FIG. 1 is ideal for practicing procedures associated with transanal minimally invasive surgery, any simulated organ or tissue portion may be used. One particular aspect of the organ 20 is that at least one tumor or defect 38 is provided and connected to the organ. As shown in Figure 1, tumor 38 is connected to the wall of organ tube 26.

Referring now to FIG. 2A , a partial side cross-sectional view of a portion of simulated organ 20 containing tumor 38 is shown. The simulated organ or tissue 20 includes a base layer or organ wall 40 . The organ wall 40 is made of a material such as silicone or another polymer configured to mimic actual living tissue and is suitably dyed. One or more base layers 40 of various thicknesses and colorations may be used to encompass the entire wall 40 . In one variant, the organ wall 40 is rigid and made of a polymeric material. Above the base layer 40 is a second layer or defect layer 42 . The defect layer 42 is of the same or smaller size than the base layer 40, which forms a raised platform for the tumor 38. The defect layer 42 is connected to the base layer 40 by an adhesive or other means known to those skilled in the art, including being formed integrally with the base layer 40 as a single unit. The defect layer 42 is made of silicon and in one variant is the same color as the base layer 40, so that the defect layer 42 blends into the background of the base layer 40. The defect layer 42 includes at least one defect or gap 44. In one variation, the defect 44 is an incision in actual tissue resulting from a tear, cutting, removal or other surgical procedure that requires surgical attention using sutures, stapling or the like to close the defect. A pre-fabricated breach in the defect layer 42 that mimics a portion, gap or void. This situation most often occurs during removal of the tumor 38 when the surrounding tissue is also removed along with the tumor 38 to prophylactically ensure that the entire tumor is resected leaving the remaining defect within the tissue. do. The defect 44 includes two opposing sides or surfaces defining a gap therebetween. Although adjacent sides or surfaces are shown as perpendicular to base layer 40, the invention is not limited thereto, and juxtaposed surfaces or sides may have any shape, for example, may be curved. there is. Defect 44 may have any shape, as will be discussed with reference to FIGS. 3A-3F.

Referring now to Figure 3A, a top view of defect layer 42 having circular defects 44 is shown. A defect layer 42 having elongated, rectangular, or elliptical defects 44 is shown in FIG. 3B. The defect 44 may be amorphous or of any shape, as shown in FIG. 3C. The defect layer 42 may be multi-part as shown in FIG. 3D, where the defect layer 42 consists of two or more adjacent defects juxtaposed to create at least one defect 44 therebetween. It includes layer pieces 42a and 42b. Another multi-part defect layer 42 is shown in Figure 3E, where a plurality of adjacent defect layer pieces 42a, 42b and 42c form one or more defects 44 therebetween. Of course, the defect layer 42 may include a plurality of defect portions 44a, 44b, and 44c as shown in FIG. 3F. The defects 44 may be entirely the same as those shown in FIG. 3F or may have different shapes. The shape, thickness and size of the defect allow the surgical trainee to practice suturing across the defect with varying degrees of difficulty. In one variation, the defect layer 42 is not of equal thickness. Instead, the thickness of defect layer 42 varies at defect location 48 to increase the difficulty of closing or sealing the defect.

Referring again to FIG. 2A , tumor 38 is located over defective layer 42 . The tumor 38 is preferably a different color from the base layer 40 or the defect layer 42 or both so that it is readily identifiable by the trainee. Preferably, tumor 38 is made of silicone or other polymer material and is red, black, blue or dark brown. Typically, the tumor 38 is a darker color than the base or defect layers 40, 42, or otherwise provides contrast thereto when viewed through a scope. In one variation, tumor 38 is connected to defect layer 42 by adhesive or other means known to those skilled in the art. In another variation, the tumor 38 is attached to, or is not connected to, but removably positioned thereon, the defective layer 42.

With continued reference to FIG. 2A , the simulated structure 20 includes a cover layer 46 positioned over the tumor 38 . In one variation, cover layer 46 overlies tumor 38, defect layer 42, and base layer 40. Cover layer 46 is preferably transparent or translucent in color and is made of a polymer material such as silicone. In one variation, cover layer 46 is the same color as base layer 40 or defect layer 42. The cover layer 46 is at least as thick as the base layer 40 or the defect layer 42, in one variant it is thinner than the defect layer 42, and in another variant it is thicker than the base layer 40. thin. Cover layer 46 is sized to cover the entire tumor 38 and defect layer 42 and, in one variant, is large enough to contact base layer 40 . In another variation, the cover layer 46 is sized to cover the entire tumor 38 and contact the defect layer 40 . Cover layer 46 is connected to base layer 40, defect layer 42, tumor 38, or two or more of the three layers using adhesive or other means known to those skilled in the art. In another variant, the cover layer 46 is smaller and connects only to the defect layer 42. In another variation, cover layer 46 is connected to both defect layer 42 and base layer 42 by adhesive or other means known to those skilled in the art. Cover layer 46 may be of any shape or size and is configured to provide the surgeon with a smooth surface instead of a layered surface for artificial tumor location. In one variation, the cover layer 46, tumor 38, defect layer 42, or base layer 40 includes surface texturing. Additionally, cover layer 46 helps keep tumor 38 and defect layer 42 sandwiched between cover layer 46 and base layer 40, which allows tumor 38 to adhere to defect layer 42. ) is useful in a modified example where it is not attached. A top plan view of the base layer 40, defect layer 42, cover layer 46, and tumor 38 is shown in Figure 4. In one variation, any one or more of base layer 40, defect layer 42, and cover layer 46 are woven such that the silicone layer may have an integrated mesh structural support or other type of reinforcement. ), formed of silicone molded onto a fabric or mesh material such as nylon or cheesecloth. Any one or more of layers 38, 40, 42, 46 may include fabric or mesh reinforcement combined with an elastic polymer such as silicone. The mesh support helps prevent sutures, staples, or suture needles from tearing through at least one of the layers, particularly through the defective layer 42 when the suture is pulled close to the gap 44. Helps prevent tearing.

In FIG. 2B , the tumor 38 and a portion of the cover layer 46 are shown being excised from the base layer 40 . The excision is performed by a trainee using surgical instruments such as a scalpel or other medical instrument to remove the tumor 38. The trainee cuts the covering layer 46 around the tumor 38 to expose the underlying defect 44 as shown in FIG. 2B, separates the tumor 38, and places the tumor 38 at that point. It will be removed by lifting it away from it. Then, as shown in Figure 2C, the trainee binds the lips or edges of the defect layer 42 together using surgical suture 48, as shown in Figure 2D, thereby sealing the defect. (44) is sutured, thereby practicing closure of the gap or wound created by surgical removal of the tumor (38). Cutting at least one layer to create an opening, removing the artificial tumor, and sealing the gap include ensuring that the simulated tissue construct is at least partially obscured from observation by the user. This is performed while positioned inside a simulated body cavity 18 of the training device.

Referring now to Figure 5, another variant is shown in which there are no pre-formed gaps or defects in the second or defect layer 42. Instead, upon resection of tumor 38, a defect is created by the user in one or more of the cover layer 46, defect layer 42, and base layer 40, and any remaining tumor portion is left to the user. is not removed by The user will then practice sealing defects created in any of these layers 38, 40, 42, 46. In one such variation, either the defect layer 42 or the base layer 40 is omitted from the construction. In another variation, the tumor 38 is positioned on the base layer 40 and the defect layer 42 is positioned over the tumor 38 such that the defect layer 42 is over the tumor 38. In this variation, a cover layer 46 may or may not be included. If a cover layer 46 is included, it may be formed integrally with the defect layer as a separate single layer. In any of the compositions described above with respect to FIGS. 2 to 5 , the compositions may be flipped upside down or the layers may be reversed or otherwise positioned accordingly as needed to provide simulated effects of real tissue. The composition can be accessed by the user from either a top or bottom direction, while the thicknesses and colors of the layers can be adjusted.

Referring now to FIGS. 6A and 6B , in any of the variations of this description, the simulated tissue construct may be comprised of a removable and replaceable module 50 instead of being formed integrally with the entire simulated organ 20. ) can be modular to be configured as. One or more modules 50 are contained within or supported within a module support 52 . The module support 52 includes a first surface 51 , a second surface 53 and one or more tumor module receiving portions 54 , 56 , 58 formed within the support 52 . Tumor support 52 may be rigid or flexible and may be made of a polymeric material. Tumor support 52 may also include a sheet of elastomeric material. The module receiving portions 54, 56, and 58 are each sized and configured to accommodate modules 50 of corresponding sizes and configurations. The modules 50 and module receiving portions 54, 56, 48 in Figure 6 are shown as circular; However, tumor module 50 may be of any shape depending on the complementary shaped receiving portions formed within module support 52. The thickness of support 52 can vary, providing a configuration with varying depths of tumor module 50 placement. Module receiving portions 54, 56, 58 may include bottom walls on which tumor modules 50 may be positioned. Alternatively, the tumor receiving portions 54, 56, 58 may be connected between modules 50 with tumors 38 or in one of the openings in one surface 51, 53. It extends between the openings of the first surface 51 and the second surface 53, connected or suspended within the tumor receiving portion. In one variation, a single tumor module 50 includes one or more tumors 38 . The module support 52 is filled with one or more tumor modules 50 and the simulated tissue construct 20 is inserted into the body cavity 18 of the surgical training device 10, framework or other torso model. This may be positioned on the base 12 of the training device 10 or suspended within the body cavity 18 of the training device 10 . The simulated tissue construct 20 and/or the training device may include attachment mechanisms, such as clips, fasteners, wires, for positioning, suspending or connecting the simulated tissue construct 20 to the training device 10. , made with hook-and-loop type fasteners and similar.

Referring particularly to Figure 6B, a module support 52 is shown comprising more than one layer. Module support 52 in FIG. 6B includes a first layer 57 connected to a second layer 55 . In one variation, the first layer 57 is made from a sheet of elastomeric material and the second layer 55 is made from any suitable polymeric material such as low-density elastomeric foam. The second layer 55 serves as a support for the first layer 57. The second layer 55 also advantageously allows the tumors 38 within the modules 50 to be positioned deep into the module support 52 relative to the first surface 51 . Provides depth. The module receiving portions 54 , 56 , 58 are formed within one or more of the first layer 57 and the second layer 55 . The module receiving portions 54, 56, 58 formed in the second layer 55 may have a different shape than the shape of the same module receiving portions 54, 56, 58 in the first layer 57. . In one variant, the tumor module 50 comprises at least a simulated tumor 38 embedded or embedded solely within the second layer 55 , while simultaneously forming the first layer 57 or the second layer 55 . ), at least one of which constitutes a fault layer on which the user can practice closure. Alternatively, instead of the first layer 57 comprising a modular receiving portion, the first layer 57 may be configured to allow a user to access a tumor 38 located within a tumor receiving portion formed within the second layer 55. It serves as a cover layer to practice cutting. In this variation, the first layer 57 may be a sheet of elastomeric material, such as silicone, and the second layer 55 is a layer of low-density elastomeric foam. The module support 52 is flat, as shown in FIGS. 6A and 6B, or, alternatively, is shaped to mimic a portion of a human anatomy, tissue or organ.

For example, Figure 7 illustrates a support 52 shaped to mimic a human uterus. The support 52 includes a first layer 57 connected to a second layer 55 . In one variation, the first layer 57 is made of any suitable polymeric material, such as a sheet of elastomeric material, and the second layer 55 is made of any suitable polymeric material, such as a low-density elastomeric foam. It is made with The second layer 55 serves as a support for the first layer 57 and advantageously the tumors 38 or tumors 38 within the modules 50 are themselves connected to the support 52 . , allowing it to be distributed throughout the support 52 and extend realistically deep into the support 52 in various positions and orientations, including embedded within the first layer 57 as shown in FIG. . The tumor or module receiving portions 61 are formed within at least one of the first layer 57 and the second layer 55 . Tumor receiving portions 61 may be pre-formed pockets within the second layer 55 or may be formed by the user cutting slits into the first layer 55 . In one variation, the tumors 38 are configured to mimic fibroid tumors commonly found in human uteri. Examples of fibroid tumors simulated by tumors 38 placed within the support include, but are not limited to, the following types of fibroids: pedunculated submucosal fibroids, subserosal fibroids, submucosal fibroids, pedunculated subserosal fibroids. field and intramural fibroids. A user may access support 52 to excise simulated tumors 38 from first surface 51 or second surface 53 via access channel or opening 63 . In one variant, the opening 63 serves solely as an opening to the hollow portion 59 or, alternatively, the support 52 provides access available to the user from above or below the planar C-shaped structure. It may have a substantially C-shaped planar configuration.

In one variant, the module support 52 of any of the variants is not flat, but is provided with a landscape that includes curves and other structures, mountains and valleys, and various textures. . The changing landscape presents the user with varying levels of difficulty in accessing each tumor location, requiring the user to navigate around artifacts and features that may obscure the tumor locations. . These structural artifacts within the tumor support 52 may be formed integrally with the tumor support 52, or may be modular in structure similar to the tumor modules 50, making the anatomical landscape modules removable and Make it interchangeable. Tumor modules 50 may include features and artifacts, e.g., made of silicone or other material, extending inwardly or outwardly from one or more of the upper and lower surfaces 51, 53 of module support 52. Alternatively, it is possible to exchange with non-tumor modules containing textures. Features within these non-tumor modules can have a variety of shapes to mimic anatomy, including adjacent organ structures or tissues. For example, a non-tumor module may include a tubular form of silicone to mimic the intestines. The non-tumor and tumor modules 50 are removably connected to the module support 52 by any means known to those skilled in the art, allowing the user to discard the module after use and then replace the discarded module. or by moving to an adjacent module 50 within the module support 52 or changing the tumor module 50 for a different tumor module 50 with different features or level of difficulty.

Variations of tumor module 50 are shown in FIGS. 8 and 9. Tumor module 50 includes a simulated tissue portion 60 connected to a support 62 . In the depicted variant, support 62 includes an upper frame 64 connected to a lower frame 66. At least one of the upper frame 64 and the lower frame 66 includes a window. A top frame 64 with a window 68 is shown in FIG. 8 . Bottom frame 66 may or may not include a window. If windows are provided in both the top frame 64 and the bottom frame 66, the windows are at least partially aligned. Support 62 is sized and configured to accommodate simulated tissue portion 60 between top frame 64 and bottom frame 66. Top frame 64 is connectable to bottom frame 66 to capture a single simulated tissue portion 60 or a simulated tissue portion 60 formed from multiple layers, and in one variant, is detachable. do. In one variation, the frames 64, 66 are spaced apart from each other using spacers 70. Additionally, at least one of the top and bottom frames 64, 66 includes one or more connection features 72 configured to secure the tumor module 50 to the tumor support 52 (not shown). 9, connection features 72 are shown as extending pegs for insertion into corresponding holes formed in tumor support 52 to provide a snap-fit engagement. Friction bonds or other fasteners or connecting means such as hook-and-loop type materials may be used on the module 50 and the module support 52 to connect the module 50 to the support 52 in a removable manner. It can be.

With continued reference to FIGS. 8 and 9 , the simulated tissue portion 60 may be any of the configurations described above with reference to FIGS. 2-5 . If windows are formed in both first and second frames 64, 66, simulated tissue portion 60 may be accessible from each side of module 50. Any layer described above as a cover layer may serve as a top layer or a bottom layer depending on the side or direction from which the simulated tissue portion 60 is accessed. For example, the base layer may also serve as a top layer or a bottom layer depending on the side or direction from which the simulated tissue portion 60 is accessed. As such, the bi-directional configurations, thicknesses and colors of the layers can be adjusted accordingly to provide the desired simulated effect.

The simulated tissue portion 60 of FIG. 9 includes a first layer 74 and a second layer 76. The first and second layers 74, 76 are made of a polymeric material such as silicone or another polymer configured to mimic actual living tissue and may include dyes of any one or more suitable colors, or mesh, fabric or other reinforcement. You can. Each of layers 74, 76 includes tumor-receiving portions 78, 80, respectively. Each tumor-receiving portion 78, 80 is a depression, indentation, half-pocket, or location of reduced layer thickness formed within layers 74, 76. Tumor-receiving portions 78, 80 are substantially aligned to form a pocket for tumor 38. Although each layer 74, 76 is shown in Figure 9 as having a tumor-receiving portion 78, 80, in one variant a single tumor-receiving portion is present in at least one of the first and second layers 74, 76. is formed in Tumor 38 is disposed within a pocket defined by one or more tumor receiving portions 78, 80 formed within one or more layers 74, 76. Tumor 38 may be attached to each layer 74, 76 or may float freely within the pocket. As shown in Figure 9, a tumor-receiving portion formed within a layer can be considered a type of defect, and a variant of Figure 9 represents a simulated tissue construct comprising two defect layers with the tumor between them. Explain. As the user approaches the simulated tissue portion 60, the user will see the target tumor location. Visualization of the target tumor 38 is enhanced by the tumor-receiving portion being thinner than the rest of the layer, taking advantage of the thinning of the layer provided by concavities or pockets. The user will then cut at the general location of the tumor cut into at least one of the layers 74, 76 to remove tumor 38. Cutting one or more layers completes the creation of a gap or complete defect, which the user can then practice sealing or otherwise closing together. In another variant, no tumor-receiving portion is formed within layers 74, 76. In this variant, the at least one tumor is disposed between two layers 74, 76, wherein the layers 74, 76 have a thickness substantially uniform with the tumor 38, with small Creates a protrusion.

Referring now to FIGS. 10A, 10B, 11A, 11B and 12, another variation of the simulated tissue portion 86 is shown. The tissue portion 86 may be unitary or modular as described above. The tissue portion 86 may be made of any suitable polymeric material, such as a reinforcing material such as fabric, mesh, nylon, or other reinforcing material, or any suitable polymeric material, which may or may not contain fillers, that will resist tearing while moving the sutures or while being sutured. and a base layer 88 formed of silicone or other elastomeric polymer. Base layer 88 is connected to a defect layer 90 that overlays base layer 88. Defect layer 90 includes a plurality of protrusions extending upward from base layer 88. Defect layer 90 may be formed integrally with base layer 88 or may be a separate layer attached to base layer 88. As can be seen in FIGS. 10A , 11A and 12 , the defect layer 90 is configured in a grid-like pattern such that the grid is raised above or protrudes upward from the base layer 88. . The grid pattern is exemplary, and any shape may be formed by the defect layer 90 to include a plurality of adjacent protrusions. These protrusions in the base layer 90 provide a platform for elevating the tumor 38a, 38b above the base layer 88 for easy resection and provide the user with locations for hooking a suture needle therein. to provide. Tumors 38a, 38b may be attached to defect layer 90 and, in one variation, cover layer 92 may be included. 10A and 11A show the base layer 88, defect layer 90, tumors 38a, 38b, and cover layer 92 in a semi-exploded view of the simulated tissue portion 86, where Layer 92 is raised above the other layers. Tumor 38a in FIG. 10A is substantially flat and is shown covered by cover layer 92 in FIG. 10B. The tumor 38b in FIG. 11A has a greater height and is substantially spherical, and FIG. 11B shows the spherical tumor 38b covered with a cover layer 92, leaving a raised portion or protrusion within the formation. 12 shows the tumor 38 being removed leaving the remaining defect 94 within the base layer 88 and the gap within the defect 94 having the defect accessed through or beneath the cover layer 92. A transverse suture needle is shown.

Referring now to Figure 13A, a polyp simulation 100 according to the present invention is shown. Polyp simulation 100 includes a defect layer 102, a mesh layer 104, a muscle layer 106, and a mold release 108.

Referring now to FIG. 13B , defect layer 102 includes a first surface 110 opposite a second surface 112 . Defect layer 102 is substantially planar and is a thin layer of silicon material in the x-y plane. The defect layer 102 includes defects 114 extending outward from the first surface 110 along the z-axis in a direction perpendicular to the x-y plane. The defective portion 114 may be of any shape. In one variation, defect 114 mimics an abnormal tissue growth, such as a polyp. In one variation, defect 114 includes a narrow elongated stem and a bulbous distal end. In one variation, the distal end of the defect is curved. In another variation, defect 114 mimics a rectal polyp or colon polyp. In one variation, defect 114 is approximately 2-5 millimeters long and 1-5 millimeters wide. In one variation, the silicon of defect layer 102 is dyed red or pink. In one variation, the defect layer includes inclusions of contrasting colored silicon.

Referring now to FIG. 13C , mesh layer 104 includes a first surface 116 opposite a second surface 118 . Mesh layer 104 is a substantially flat, thin layer containing strands 120 of fibers made of nylon or other polymer in the x-y plane. In one variation, mesh layer 104 is made of LYCRA. In one variation, mesh layer 104 can be stretched in any direction. In another variation, the mesh layer has bi-directional stretching properties. Strands of polymer fibers form a web or net. Mesh layer 104 may be woven and have a uniform pattern. Mesh layer 104 is pink, transparent, or white.

Referring now to FIG. 13D , muscle layer 106 includes a first surface 122 opposite a second surface 124 . The muscle layer 106 is substantially flat and is a thin layer of silicone material in the x-y plane. In one variation, the muscle layer is yellow.

Mold release 108 is a mold release agent, typically in liquid form, that is sprayed to form a mold release area or layer. Mold release formulations are suitable for use on silicone. In one variation, mold release layer 108 is a mold release agent alternative or substitute. Mold release layer 108 prevents at least a portion of the silicon layer surface from bonding to an adjacent silicon surface. In one variation, the mold release 108 prevents a portion of the defect layer 102 from bonding to the adjacent muscle layer 106. In another variation, the mold release 108 prevents at least a portion of the defect layer 102 and mesh layer 104 combination from bonding to the adjacent muscle layer 106.

Referring now to FIGS. 14A-14B , a muscle mold 126 for molding the muscle layer 106 is shown. Muscle mold 126 includes a first well 128. Wells 128 are circular to create circular muscle layer 106. First well 128 may be of any shape. Uncured silicone is poured into the mold and cured to form the muscle layer. A mold release may be used to assist in removing the cured layer. The removed layer can be washed with alcohol to remove any mold releases.

Referring now to FIGS. 15A-15B, a defect mold 130 for molding the defect layer 102 is shown. The defect mold 130 includes a first well 132 with a first depth and a second well 134 with a second depth. The second depth is greater than the first depth. The second well 134 is located within the first well 132. The second well 134 is for forming the shape of a polyp or other defect 114. The shape of the second well 134 corresponds to the shape of the defective portion 114. The shape of the first well 132 is circular to form a circular defect layer, but it may have any shape. In one variation, the size and shape of the first well 132 is the same size and shape as the first well 128 of the muscle mold 126 for creating the muscle layers 106, and has the same size and shape. The defect layers 102 can be easily aligned and connected to form a nice patch-like simulation 100. The second well 134 is formed such that the second well is within the periphery of the first well 132 . The second well 134 creates a defect 114 that is surrounded by the remainder of the defect layer 102. Uncured silicone is poured into the defect mold 130 and cured before being removed. A mold release may be used to facilitate removal of defect layer 102 from defect mold 130. In another variation, pieces of cured silicone of contrasting colors are placed within the second well 134 forming the shape of a polyp or other defect. For example, one or more red, cylindrical pieces of cured silicone sized to fit inside second well 134 prior to pouring uncured silicon into the defect mold or to form defect layer 102. For this purpose, uncured silicon is poured into the defect mold 130 and then placed into the second well 134. The result is that contrasting colored silicon pieces will be embedded within the defect layer 102 at the location of the defect to provide a customized and more realistic configuration of the specific defect being simulated.

In one variation, defect layer 102 is connected to mesh layer 104 such that second surface 112 of defect layer 102 faces first surface 116 of mesh layer 104. In one variation, an adhesive may be used between defect layer 102 and mesh layer 104, or, in another variation, mesh layer 104 while the silicone in defect layer 102 is not cured. ) is located into the defect layer 102. As a result, mesh layer 104 is embedded within defect layer 102. When the mesh layer 104 is embedded within the defect layer 102, the resulting combination has a proximal surface that is the first surface 110 of the defect layer 102 and a distal surface that is the surface proximal to the mesh layer 104. Mold release 108 is applied to the distal surface of the defect/mesh layer combination in selective areas. In one variant, the mold release 108 is applied to the center of the perimeter such that an annular area without mold release 108 surrounds the area where the mold release is applied. In another variation, the mold release 108 is applied beneath the defect 114 such that the area of the distal surface without the mold release surrounds the area with the mold release 108 thereon. The area surrounding the mold release area does not have a mold release 108 thereon to create an annular bond between the muscle layer 106 and the defect layer 102. The area with the mold release 108 thereon will not bind the muscle layer 106 to the defect layer 102, making it possible to separate them at the location of the defect 114. Next, the muscle layer 106 is connected to the distal surface of the defect/mesh layer combination. In one variant, the muscle layers 106 are connected with adhesive. In another variation, a muscle layer 106 is applied to the distal surface of the defect/mesh layer combination while the silicone of the defect layer 102 continues to harden to embed the muscle layer 106 into the defect/mesh layer combination. It doesn't work.

In another method of forming a polyp simulation (100), the forming process involves two molds: a muscle mold (126) and a defect mold (130). Silicone is cast into muscle mold 126 to form muscle layer 106. The silicone of muscle layer 106 is allowed to harden. The muscle layer 106 is then removed from the muscle mold 126. The muscle layer 106 is cleaned using isopropyl alcohol. The mold release 108 is applied only to the center of the muscle layer 106 or to the bottom of the defect 114. Mold release 108 is applied to first surface 122 using a stencil. The muscle layer 106 with mold release 108 is left. 16, silicon is cast into defect mold 130 to form defect layer 102. While the silicon in the defect mold 130 is not cured, a mesh layer 104 having a shape that matches the shape of the first well 132 is placed on the uncured silicon in the defect mold 130, resulting in It connects there. The muscle layer 106 with the mold release 108 is positioned on the mesh layer 104 such that the first surface 122 with the mold release 108 applied thereto faces the mesh layer 104 and the defect layer 102. It is located above. The muscle layer 106 with the mold release 108 is positioned face down onto and toward the uncured silicon and mesh layer 104 of the defect layer 102. While it is not hardening, the muscle layer 106 is pressed into the defect layer 102 using, for example, gloved fingers to remove any air bubbles. The silicon of defect layer 102 is allowed to cure and the resulting polyp simulation 100 is removed from defect mold 130. All of the layers have the same shape and are overlaid in an aligned manner with each other to form a single piece polyp simulation 100. As a result of the mold release 108, portions of the muscle layer 106 are not attached to the defect and mesh layers 102, 104, and the muscle layer 106 without the mold release 108 thereon is not attached to the defect and mesh layers 102, 104. Attached to (102, 104). The selective attachment advantageously creates a polyp simulation 100 suitable for practicing polyp removal, and the mesh layer creates a polyp simulation suitable for practicing suturing after the polyp has been removed.

In another method, the defect layer 102 is allowed to cure with or without the mesh layer 104. The second layer 106 is allowed to cure. The stencil is placed on top of one of the defect layer 102 and the second layer 106. The stencil has one or more openings. One or more openings are arranged on the stencil in a pattern configured for attachment. One pattern includes a plurality of randomly spaced dots or circles. The uncured silicone or adhesive is applied on the stencil at the locations of the openings such that the uncured silicone or adhesive passes through the one or more openings and contacts the layer overlying the stencil. The stencil is removed along with any excess adhesive or uncured silicone, leaving behind a pattern of uncured silicone or adhesive. The other of the defect layer and second layer 106 is then placed on top of and attached to the other layer. The pattern for the adhesive on the stencil may be a circumferential pattern or a circular pattern at the location of the defect, or any other pattern. The stencil openings may be, for example, a single, continuous pattern forming a larger circle around the defect and/or along the perimeter of the layers to ensure that the two layers do not adhere outside the applied adhesive or applied uncured silicone. Or it may be a multi-aperture pattern of multiple circles. A mold release may or may not be used between the two attached layers.

One or more resulting polyp simulations 100 are then attached to different parts of the simulated tissue structure. For example, a patch-like polyp simulation 100 is attached with adhesive to the inner surface of a tubular simulated colon, in one variant made of silicone. The Foley simulation 100 is coupled to a simulated colon model such that the defect 114 extends into the lumen of the colon.

In another variation, muscle layer 106 and defect layer 102 are joined together without an additional mesh layer 104 for ease of manufacturing. In another variation, muscle layer 106 and defect layer 102 are fully cured separately and attached together without any mold release 108. In another variant, the defect 114 is not formed as an integral protrusion extending from the first surface 110 of the defect layer 102. Instead, defect 114 is a separate piece located between muscle layer 106 and defect layer 102. In another variant, the defect 114 is not formed as an integral protrusion extending from the first surface 110 of the defect layer 102. Instead, the defect 114 is a separate piece positioned between the muscle layer 106 and the defect layer 102 such that the defect 114 floats between the two layers 102, 106.

Polyp simulation 100 is used with a simulated rectum. The simulation 100 advantageously includes a mesh layer 104 embedded therein, which allows the user to practice sealing techniques after practicing removal of the defect 114. This simulation 100 increases the difficulty of removing defects because the layers 106 and 102 do not separate easily due to the annular region having no mold release 108. The mesh layer 104 allows the polyp simulation 100 to be sealed. Suturing techniques are practiced by the user without damaging the surrounding silicone. Connecting the two muscle layers 106 while the defective layer 102 continues to uncure increases the difficulty of separating the two layers and results in a formation that increases the accuracy of the simulation. The embedded mesh layer 104 prevents the suture from tearing, slicing or cutting through the silicone. Additionally, separating the muscle layer 106 from the defective layer 102 becomes more challenging as a weak vacuum is created between the two layers 102, 106 at the location with the mold release 108. The vacuum leaves the muscle layer 106 and the defect/mesh layer very close to each other, almost mimicking adhesion. This vacuum can be released by pulling the layers apart with surgical instruments while creating a space between the two layers 102, 106, allowing the user to practice this technique. This makes separation easier depending on the application and/or anatomy for the variant there will be no mold release between the two layers resulting in muscle and defect layers being joined along the entirety of their interfacing surfaces.

Referring now to Figures 17A-17C, a simulated tissue model 200 for practicing a surgical procedure is shown. The model 200 shown in Figure 17 is configured to mimic a portion of a colon or intestinal section; However, the present invention is not limited to the colon or intestines. The overall model 200 may be configured to mimic at least a portion of any organ or tissue section for which it is desired to practice specific surgical procedures. The simulated tissue model 200 includes an interior surface 202 and an exterior surface 204 that together define side walls having a predetermined thickness. The simulated tissue model 200 of FIG. 17A has a cylindrical shape with a central lumen 206 extending along the longitudinal axis between an opening at the proximal end and an opening at the distal end to approximate a colon, rectum, or intestinal section. have One of the openings at the ends may be omitted. Either one or more of interior surface 202 and exterior surface 204 may include surface features or textures that mimic real tissue. For example, transverse folds and/or mesorectal layer may be included. Simulated transverse wrinkles may be an obstacle to the movement of the surgeon's instruments and/or may make direct visualization of the lesion difficult. Therefore, the presence of transverse wrinkles simulates the challenges a surgeon may encounter when performing transanal procedures. The simplified model 200 will omit the horizontal creases. The simulated mesorectal layer included with model 200 is advantageously used to access target tissue lesions located closer to the anal skin line, which are much more difficult to move due to limited instrument movement and steep angles of approach. Provides a reference plane.

The side walls separate the interior space defined by the central lumen 206 of the simulated tissue model 200 from the exterior space of the model 200 . Module 200 includes one or more openings 208 extending through the sidewall from interior surface 202 to exterior surface 204. Each opening 208 is molded and configured to receive a module or pod 210. The sidewall has a substantially uniform thickness in the area surrounding the pod-receiving openings 208. A plurality of openings 208 are formed along the length of model 200 from the proximal end to the distal end and around the entire side wall at various locations. The side walls of model 200 are made of a rigid or semi-rigid material such as plastic. In other variations, the sidewalls of model 200 are smooth and/or combined with soft portions and semi-rigid or rigid portions. The side walls of model 200 are configured to enable pods 210 to be attached to model 200.

Each pod 210 includes a simulated tissue portion 212 connected to a tissue carrier 214, also referred to as a cap. Tissue carrier 214 is shown in FIG. 18. Carrier 214 includes a flange 216 connected to frame 218 . In one variation, frame 218 is substantially cylindrical in shape and has a closed distal end with an opening 220 at the proximal end. Flange 216 is located at the proximal end and at least partially surrounds opening 220. Flange 218 defines substantially circular proximal opening 220 , and flange 216 extends at least along a portion of the periphery of opening 220 . Flanges 216 are substantially perpendicular to the cylindrical side walls of frame 218 and extend radially outward from the proximal end. Flange 216 includes a surface 222 connected to and configured to suspend tissue portion 212 . Pod 210 is configured to serve as a tissue insert filling openings 208, and flange surface 222 is configured to match the portion of interior surface 202 on which it is received. For example, if the interior surface 202 of the model 200 is concave, the surface 222 of the flange 216 will also be a correspondingly concave shape. Frame 218 includes oppositely disposed detents 224 configured to bend inward and then spring back outward to connect and disconnect pod 210 from model 200 . The user's fingers are used to press the detents 224 inward while inserting the pod 210 into the opening 208 of the model 200. The pod 210 can be inserted from the interior space of the model such that the side wall of the model 200 slopes above the detents 224, which allows the side wall of the model 200 to be positioned between the detents 224 and the flange 214. and thereby bending the detents inward to connect the pod 214 to the model 200 and allowing the detents 224 to bounce back outward after passing the sidewall. The interior surface 202 of model 200 includes a recess 226 surrounding each opening 208, as shown in FIG. 19. Each recess 226 extends around the openings 208 such that the connected tissue portion 212 or flange 216 is substantially flat or coplanar with the interior surface 202 of the model 200. It is sized and configured to accommodate the flange 216 of the pod 210. Pod 210 with tissue portion 212 connected thereto is shown inserted into opening 208 of model 200 in FIGS. 17A and 19 . Tissue portion 212 is connected to flange 216 of pod 210. In particular, the tissue portion 212 is connected to the surface 222 of the flange 216 by an adhesive or bond such that at least a portion of the tissue portion 212 spans or suspends over the proximal opening 220 . The suspended tissue portion 212 is free to bend and straighten within the pod 210 and can be freely cut in the simulation procedure. Following the procedure, pod 210 can be removed from model 200, discarded, and replaced by a new pod 210 into the cylindrical sidewall of model 200 for subsequent training and practice on surgical procedures. there is. Each pod 210 with a tissue portion 212 is configured for attachment to a simulated model 200 having a tubular shape. The tubular shape may be configured to open like a clam for inserting and removing pods 210.

The tissue portion 212 of each pod 210 is flexible and includes at least a flat first layer 228 . First layer 228 includes a first side and a second side. First layer 228 is connected to flange surface 222 with the first side facing the interior of model 200. First layer 228 is sized and configured to overlay opening 220 and attach to flange 216 . In this way, the connected first layer 228 covers the opening 220 . The central portion of first layer 228 is free to bend in response to impact by surgical instruments. The first layer 228 is also configured to be separated with a blade, such as a scalpel or other instrument, grasped by a surgical instrument, or otherwise manipulated as desired by a surgeon practicing a surgical procedure. . The central portion of the first tier 228 is suspended in a trampoline-like manner. The first layer 228 is made of silicone and is a mesh layer, fiber, fabric or mesh layer that imparts seamable qualities to the first layer 228 that enable the first layer 228 to hold sutures without tearing. It may or may not contain other reinforcing materials. In another variant, first layer 228 is made of KRATON®.

In another variation, the tissue portion 212 includes a substantially flat first layer 228 and a simulated target or tumor 232 connected to the first layer 228 . The first layer 228 is connected to the flange 218 with the first side facing the interior of the model 200. The simulated tumor 232 is connected to the first side of the first layer 228 such that the simulated tumor 232 faces the interior of the model 200 and, in one variant, protrudes toward the longitudinal axis. In this variation, both first layer 228 and simulated tumor 232 are made of silicone. First layer 228 is generally dyed to have the same color as the surrounding interior surface 202 of model 200 such that it is indistinguishable from the surrounding interior surface 202. First layer 228 is generally pink or red. The simulated tumor 232 may be stained a color that is darker than or contrasts with the first layer 228, such as dark red, brown, or black. Simulated tumor 232 extends outward from the first surface of first layer 228 . In one variation, the polyp simulation 100 of FIGS. 13-16 is attached to the pod 210.

In another variation, the tissue portion 212 includes a substantially flat first layer 228 having a first side and a second side, a flat second layer 230 having a first side and a second side, and a simulated Includes target or tumor (232). The first layer 228 is substantially flat and is connected to the flange 218 with the first side facing the interior of the model 200. The first layer 228 is made of silicone and dyed pink or red. Second layer 230 is substantially flat and includes a first side and a second side. The second layer 230 is connected to the first layer 228 such that the first side of the second layer 230 faces the second side of the first layer 228 . In one variation, an adhesive is used on at least a portion of the first or second layer to join the two layers together. In another variation, one of the layers 228, 230 is applied to the other layer while in an uncured state and allowed to cure and adhere to the other layer, which is more easily separated than using an adhesive. causes them. The second layer 230 is made of silicone and dyed yellow. The simulated tumor 232 is connected to the first side of the first layer 228 or extends outwardly from the first side of the first layer 228 . Attached to or formed integrally with it. The second layer 230 is yellow and simulates the submucosa layer. The first layer 228 is pink and simulates the rectal wall. Simulated tumor 232 simulates a tumor, lesion, or other surgically desirable target. In one variation, second layer 230 has a planar configuration with an outer surface and an inner surface and is sized to the same size and shape as first layer 228; Tumor 232 is sized to be smaller than first and second layers 228, 230. A surgeon practicing a transanal approach will insert surgical instruments into openings in one or more of the proximal or distal ends of model 200. The surgeon will practice using a scalpel to make an incision into the first layer 228 and extend the incision through the first layer 228 and around the simulated tumor 232. The second layer 230 provides an indication or warning to the surgeon to stop cutting and not to cut into the second layer 230. Accordingly, the surgeon can practice carefully and precisely excise the simulated tumor 232. Accordingly, during visualization, the yellow second layer 230 serves as a reference plane for the surgeon. In one variation, at least a portion of first layer 228 and a region of first layer 228 adjacent to or beneath the simulated tumor 232 to facilitate resection of tumor 232 It is not attached to the second layer 230 with an adhesive. In one variation, the first layer 228 is attached to the second layer 230 only peripherally around the simulated tumor 232, such that when cutting is made within the perimeter of the attachment, the first layer 228 ) can be easily separated from the second layer 230. Deployment of this type of adhesive beneficially helps guide the surgeon to make a more precise excision. In another variation, the area of the first layer 228 beneath the simulated tumor 232 can be glued using the surface attachment properties of similar materials without adhesive or on top of another layer in the fabrication of the tissue portion 212. It is attached to the second layer 230 by curing the layer. After the tumor layer 232 is removed, the surgeon can practice closing the resulting defect or gap with sutures. The first and/or second layers 228, 230 may be made of a sealable material. For example, the sealable material may include a thermoset polymer, a thermoplastic elastomer, or a thermoplastic elastomer overmolded onto the fibers, mesh, or fabric. You can. Fabric mesh materials may also have the property of being able to stretch in two directions.

At least a portion of the tissue portion 212 may be suspended by the frame 218 such that there is a space behind the simulated tissue portion 212 to allow manipulation of the simulated tumor 232 and/or tissue portion 212. You can. The suspended portion is the middle portion of the tissue portion 212, the peripheral portion of which is attached to the frame 218. As a result, the attached tissue portion 212 has elasticity or elasticity, simulating the elasticity of the rectal wall, which in one variant is different from the elasticity of the surrounding material.

Referring now to Figure 20, another variation of the organizational model will now be described. Figure 20 illustrates a mandrel 234 for forming a simulated tissue model in accordance with the present invention. The mandrel 234 is provided with at least one depression 236. Mandrel 234 may also include one or more slits 238 substantially perpendicular to the longitudinal axis for forming transverse wrinkles within the resulting tissue model. A section of the resulting tissue model is shown in Figure 21. A first layer 240 of uncured silicone is applied uniformly around the mandrel 234 of FIG. 20 to form a model 200 having a substantially cylindrical shape mimicking an intestinal section or colon. ) and allowed to cure. First layer 240 may include multiple applications of uncured silicone applied using the rubbing of a brush or other device that pours or transfers the silicone. The silicone is allowed to cure, wherein the first layer has an inner surface (244), an outer surface (246), and at least one recess (242) formed in the outer surface at the location of the at least one mandrel depression (236). causes (240). A second layer 246 sized and shaped to fit within recess 242 is provided and positioned within recess 242 . Second layer 248 is substantially flat and has an interior surface and an exterior surface. The second layer 248 is positioned within the recess 242 with its inner surface facing the outer surface 246 of the first layer 240. The second layer 248 is made of yellow dyed silicone that bends to fit the first layer 240. An adhesive may be used to join second layer 248 to first layer 240. The third layer 250 is then placed on the first layer 240 and the second layer 248 to capture the second layer 248 between the first layer 240 and the third layer 250. Applies. The third layer 250 is made of transparent or pink silicone. Third layer 250 is typically applied uniformly while the silicone is not cured to form a layer having a substantially uniform thickness. As the silicone cures, the third layer 250 naturally attaches to the first layer 240. A simulated tumor 252, lesion, or tissue target is attached to the interior surface 244 of the first layer 240 at a location adjacent inwardly from the second layer 248. In one variant, the second layer 248 is patch-shaped with a flat configuration having an outer surface and an inner surface and is sized smaller than the first layer 240; Tumor 252 is sized to be smaller than second layer 248. The simulated tumor 252 protrudes inwardly from the inner surface 244 of the first layer 240. A plurality of simulated tumors 252 are positioned throughout the tissue model 200, connecting the plurality of recesses 242 and the second layers 248. The simulated tumor 252 can also be formed as a layer having an inner surface and an outer surface with the outer surface connected to the inner surface of the first layer 240 . The first layer 240 provides an inward-facing substantially smooth interior surface with one or more simulated tumors 252 protruding inward. The outer surface of the third layer 250 is substantially smooth, meaning that the interface with the second layer 240 and its first layer 240 and third layer 250 is substantially smooth. This is because it is filled with wet silicone. Thereby, a simulated tumor-containing intestinal section is provided with the marking layer provided by the second layer (248) positioned behind the simulated tumor (252). In another variation, the adhesive is applied to the first layer (248) at a location around the location of the simulated tumor (252) such that the central portion of the adhesive-free second layer (248) is easily separable from the first layer (240). It is applied between 240) and the second layer 248. Additional adhesive may be applied between the second layer 248 and the third layer 250 to keep the second layer 248 in place when the first layer 240 and the attached tumor 252 are removed. there is. In another variation, no adhesive is applied between the first layer 240 and the second layer 248 so that the two adjacent layers can be easily separated. It is desirable to allow first layer 240 to separate from second layer 248 in preselected areas, which provides feedback to the surgeon regarding appropriate incision location. For example, if the trainee makes the incision far from the location of the tumor 252, the trainee will have a difficult time separating the adhered areas between the first and second layers 240, 248; On the other hand, an incision made closer to the tumor 252 will cause the surgeon to encounter a non-adhesive area adjacent to the tumor 252, and the surgeon will more easily separate the two layers 240, 248. In another variation, no adhesive is used between the first layer 240 and the second layer 248, but this is because both layers are made of silicone, and one cures on top of the other to form an adhesive. Because natural adhesion, without any applied bonding, causes the layers to stick together, they can still be easily separated. When the trainee surgically accesses the simulated tumor 252 from within the central lumen of the model through either the distal or proximal opening and begins cutting the first layer 240, the second layer 248 Provides a marking or visual reference layer to deter cutting too deeply through or into the second layer 248. After removing the tumor 252 by cutting around the tumor 252 into the first layer 240, the trainee can see a change in color as the second layer 248 is visualized and accessed through the incision, which the trainee This trains you to be more precise when making incisions. First layer 240 may include fibers, mesh, or fabric configured to hold sutures so that the surgeon can practice placing sutures close to gaps created within first layer 240. Reinforced first layer 240 helps retain the sutures to prevent them from tearing through the silicone and may include a stretchable mesh material.

In another variation of the simulated tissue model 200 illustrated in FIG. 22 , uncured silicone is poured or brushed onto the mandrel and removed after it has cured to form first layer 240. do. The resulting first layer 240 molded around the cylindrical mandrel forms a substantially cylindrical shape with an open proximal end and/or an open distal end, and an interior surface 244 and an exterior surface 246. First layer 240 may include wrinkles extending circumferentially and at least partially perpendicular to the longitudinal axis. The first layer 240 is dyed pink. One or more simulated tumors 252 (not shown in FIG. 22) are attached to the interior surface 244. The simulated tumor 252 is made of dark colored silicone. A plurality of second layers 248 are attached to the outer surface of first layer 240 at locations opposite the simulated tumors 252 . The second layer 248 is yellow dyed silicone and is attached with adhesive. The second layer 248 is patch-shaped, having a planar configuration with outer and inner surfaces sized smaller than the first layer 240 . Tumor 252 is sized to be smaller than second layer 248. The inner surface of the second layer 248 faces the outer surface 246 of the first layer 240. In this embodiment, the interior surface 244 of the first layer 240 is substantially smooth. In particular, the interior surface 244 of the first layer 240 is smooth in the area surrounding the simulated tumor 252. Simulated tumor 252 protrudes inward from interior surface 244. The yellow second layer 248 can be slightly visible through the first layer 240. The outer surface 246 of the first layer 240 terminates with patches protruding out of the second layer 248. Accordingly, model 200 does not appear smooth from the outside as there is no overcoat smoothing layer applied; However, model 200 appears smooth from the inside. The first layer 240 may include mesh, fabric, or fiber to facilitate sealing as described above. The yellow second layer 248 provides an indicator layer to prevent the trainee from puncturing the simulated fat layer. After going through the first layer 240, the trainee will visualize a greater color contrast or brighter color relative to the second layer 248 below. The trainer may examine the model 200 following the simulation to see whether the second layer 248 has been perforated to provide feedback to the trainee.

In any of the variations, the second layer 246 is such that the trainee can separate the first layer 240 and the attached tumor 252 from the remainder of the model 200, particularly from the second layer 246. The outer surface 246 of the first layer 240 generally allows the central region of the second layer 248 to be easily separated from the outer surface 246 of the first layer 240 to assist in separating the may be attached along its periphery. Alternatively, the second layer 248 may be selectively attached such that not all of the interior surface of the second layer 248 is attached to the exterior surface 246 of the first layer 240.

Referring now to Figure 23, in another variation of model 200, a first layer 240 of uncured silicone is applied to a cylindrical mandrel. The first layer 240 is colored pink and allowed to cure. A second layer 248 of silicone is then applied on the outer surface 246 of the first layer 240 and the second layer 248 is allowed to cure to adhere to the first layer 240. . The model 200 is then removed from the mandrel tube-shaped sleeve sized and shaped to resemble a colon or intestine section with optional transverse folds 254 extending inwardly into the central lumen 206. . A simulated tumor 252 made of silicone is then randomly attached only to the inner surface 244 of the first layer 240. The first layer 240 is pink and simulates the rectal wall. In one variation, the first layer 240 may be a mesh, fabric, or fabric to create a sutureable wall configured to stretch under forces applied by the user as well as to hold sutures without tearing through the silicone layer. Contains fiber. The second layer 248 is yellow and simulates the submucosa layer. The outer surface of second layer 248 will be generally smooth along the length of module 200, with wrinkles 254 protruding inward toward the longitudinal axis. The interior surface 244 is also generally smooth along the length of the model 200, with wrinkles 254 protruding into the central lumen 206. The smooth inner surface 244 is interrupted by inwardly protruding simulated tumors 252 attached to the inner surface 244. The simulated tumors 252 have a color such as black or dark red that contrasts with the color of the first layer 240 . The smooth interior and exterior surfaces of model 200 provide a realistic approach for practitioners. Additionally, a user accessing the lesion to be ablated from the central lumen 206 will be able to make an incision into the first layer 240; Therefore, the first layer 240 can be cut. After the first layer 240 has been pierced, the user will directly visualize the yellow second layer 248, indicating to the user that the first layer 248 has been pierced and that the incision has been made in the second layer 248. ) will serve as a reference layer to indicate that further progress should not be made. Because the second layer 248 was not adhered to the first layer 240 and was allowed to cure on the first layer 240, the first layer 240 along with the simulated tumor 252 ) is easily separated from. After the tumor 252 is removed, the user may suture the resulting gap within the first layer 240 to which the simulated tumor 252 is attached by passing sutures into the first layer 240 and close the gap. You can practice it. The advantage of this variation of model 200 is that it allows the tumor 252 to be positioned anywhere along the length of the model so that the user can practice removing the tumor 252 located in hard-to-reach areas. do.

Now referring to Figures 24 and 25, another variation of model 200 will be described. FIG. 24 illustrates a mandrel 234 with outwardly facing detents 256 protruding out from the outer surface of the mandrel 234 . After a first layer 240 of silicone or other material is molded onto the mandrel 234, a tube-shaped model 200 is formed into a model with a plurality of recesses 242 formed in the first layer 240. It is removed from the mandrel 234, leaving behind 200). Recesses 242 extend outward from the interior surface 244 to form wells for receiving simulated tumors 252 within the recesses 242 . Simulated tumor 252 may be formed as part of a pod. The polyp simulation 100 described above with respect to FIGS. 13A-16 may be positioned within the recesses 242 and attached to the inner surface of the first layer 240 to the base of the well. In one variation shown in FIG. 25 , tumor pod 258 includes a first layer 260 having an interior surface 262 and an exterior surface 264 . The first layer 260 is substantially flat and shaped to correspond to the shape of the recess 242 into which it is inserted. First layer 260 is made of silicone and is pink, matching the color of first layer 240. The simulated tumor 252 is attached to the inner surface 262 of the first layer 260. Tumor 252 is also made of silicone and is a darker color than first layer 260 to provide a contrasting color representing the tumor. Tumor 252 extends outward from interior surface 262 of first layer 260, forming a protrusion. Tumor 252 has a smaller area than first layer 260. Tumor pod 258 includes a second layer 266 having an interior surface 268 and an exterior surface 270. The second layer 266 is made of yellow silicone to simulate the mesorectum. The second layer 266 is attached to the first layer 260 by connecting the layers 260, 266 to each other while one of the layers is still uncured and allowing the uncured layer to cure on the other layer. Thereby, the first layer 260 is more easily separated from the second layer 266 compared to being attached with an adhesive. In another variation, first layer 260 is adhered to second layer 266 by calendaring the surface of one of layers 260, 266 with adhesive and adhering the two layers together. The inner surface 268 of the second layer 266 faces the outer surface 264 of the first layer 260 when attached. In another variation, the adhesive is applied to the outer surface 264 of the first layer 260 or the second layer to create an area between the first layer 260 and the second layer 266 that is not adhered together. It is selectively applied around the location of tumor 252 on the interior surface 268 of 266, creating areas that can be more easily separated from each other. The thickness of the combined first layer 260 and second layer 266 is approximately equal to the depth of the recess 242 in which it is located, which separates the inner surface 262 of the first layer 260 from the first layer 260. It is made substantially in contact with or flush with the inner surface of layer 240. In another variation, the combined thickness of first layer 260 and second layer 266 is slightly less than the overall thickness of first layer 240 such that tumor 262 is slightly recessed. The user will visualize the tumor 252 and access it using instruments through the central lumen 246 from one or more openings at the ends of the model 200. The user will cut through the first layer 260 of the tumor pod 258 at the location of the tumor 252 and guide the blade around the tumor 252 to excise the tumor. The user will practice cutting deeply by visualizing when the yellow second layer 266 is reached, taking care not to cut into the second layer 266. First layer 260 and attached tumor 252 are separated from second layer 266 and removed from model 200. The user can repeatedly practice this removal at different locations along the depth of model 200. Recesses 242 allow modular pods 258 to be inserted while maintaining a substantially smooth outer surface and a smooth inner surface of model 200 while also providing a reference layer for practicing depth perception where cuts are made. makes it possible. The second layer 266, which serves as a reference layer, cuts a cut path from the inner surface 262 of the first layer 260 through the first layer 260 to the outer surface 264 of the first layer 260. and then helps define the separation along the interface between the first layer 260 and the second layer 266. The first layer 260 and attached tumor 252 are pooled from the second layer 266. First layer 260 may also include a mesh material that allows the layer to hold sutures after tumor 252 is removed. The user can also practice closing the remaining gaps with sutures. The seamable layers may comprise silicone with a mesh material as described above, or, alternatively, may be made of KRATON®, such as VERSAFLEX®, without mesh, fabric or fiber reinforcement.

A rectal model 300 that can be completely sutured is disclosed. Rectal model 300 is made of silicone with an embedded mesh material. That the rectal model 300 is fully sutureable means that the entire length of the tubular rectal model 300 includes mesh and is sutureable, allowing surgeons and users to practice suturing techniques on the simulated intestine. It means to do it. Silicone itself does not help to enable easy and realistic suturing, as sutures do not hold the silicone material but rather easily cut it. The addition of a mesh such as SPANDEX prevents the suture from cutting through the silicone. As a result, silicone rectal models are too thick and therefore provide too much resistance for the suture to pass through the full thickness. Trainees need to practice specific suturing techniques, such as purse strings or simply closing the defect. The present invention provides a rectal model capable of such suturing.

Referring now to Figure 26A, mesh layer 302 is shown. Mesh layer 302 includes a first surface 304 opposite a second surface 306 . Mesh layer 302 is a substantially flat, thin layer containing fiber strands made of nylon or other polymer in the x-y plane. In one variation, mesh layer 302 is made of LYCRA. In one variation, mesh layer 302 is SPANDEX. In one variation, mesh layer 302 may be stretched in any direction. In another variation, the mesh layer has bi-directional stretching properties. Strands of polymer fibers form a web or net. Mesh layer 302 may be woven and have a uniform pattern. Mesh layer 302 is red, pink, or white.

Continuing to refer to Figure 26A and further referring to Figure 26B, the appropriate length and width of mesh layer 302 are provided. As shown in FIG. 26B, the mesh layer 302 is formed into a cylindrical shape, and longitudinal seams 308 are formed using a bar-sealer. The bar-seal heat-seals the mesh layers 302 together to form seam 308. The cylindrical mesh layer 302 forms a sleeve 312 with a central lumen 310 as shown in FIG. 27 .

Referring now to Figures 27-28, a mandrel 314 is provided. The mold release agent is applied to the mandrel 314, such as by spraying or brushing the mandrel 314 with a mold release. Mold release substituents or alternatives may also be used. After the mold release is applied to the mandrel 314, the mandrel 314 is inserted into the central lumen 310 of the sleeve 312. The sleeve 312 is constructed and sized to fit over the mandrel 314, which has a size and shape that mimics the actual rectum. The inner diameter of the sleeve 312 has a diameter equal to or slightly larger than the outer diameter of the mandrel 314. The mandrel 314 includes a rotation pin 316 coupled to a motor configured to rotate the mandrel 314 about its longitudinal axis. As the mandrel 314 rotates, uncured silicone is applied to the sleeve 312 of the mesh. Uncured silicone may be applied, for example, to the rotating mandrel 314 at the proximal and distal ends of the sleeve 312 or prior to inserting the mandrel 314 into the sleeve 312. Uncured silicone is applied uniformly with a brush or other dispensing mechanism. Uncured silicone is applied over and repeatedly over previous applications of silicone in sleeve 312. In one variation, uncured silicone is applied before mandrel 314 is inserted into sleeve 312.

After application of the silicone is complete and the mesh is fully covered, or until the desired thickness of the product is achieved, the silicone is allowed to fully cure. The cured silicone and mesh product are then removed from the mandrel 314. The result is a mesh layer 302 embedded in silicone, forming a tubular rectal model 300 that can be sutured along its entire length. Embedding the sleeve 312 of the mesh within the silicone inhibits cutting and tearing of the silicone during practice of suturing the rectal model 300. As a result, rectal model 300 is fully sutureable, which enables complex suturing techniques such as coin purse or Perth string placement as shown in FIG. 29. In Figure 29, a fully sutureable rectal model 300 is shown along its longitudinal axis 318. Sutures 320 are passed in and out of rectal model 300 in a daisy-like pattern without tearing the rectal model walls as a result of the embedded mesh construction. The ends of the sutures 320 may then be tightened like a coin purse to constrict the central lumen of the rectal model 300.

In one variation, instead of the cylindrical sleeve 312 of mesh material, one or more strips of mesh material may be placed directly over the mandrel and held in place, or uncured silicone brushed onto the mandrel 314. This is followed by successive applications of uncured silicone in a flat manner around the mandrel 314 to embed one or more strips of mesh material.

2012, entitled “Simulated tissue structure for surgical training,” claiming priority to U.S. Provisional Patent Application No. 61/549,838, filed October 21, 2011, entitled “Simulated tissue structure for surgical training.” U.S. Patent Application Serial No. 13/656,467, filed October 19, is hereby incorporated by reference in its entirety.

It should be understood that various modifications may be made to the embodiments of the system disclosed herein. Accordingly, the above description should not be construed as limiting, but merely as examples of preferred embodiments. Those skilled in the art will contemplate other modifications within the spirit and scope of the present disclosure.

Claims (20)

As a simulated organizational model,
A substantially cylindrical tube having side walls having an interior surface and an exterior surface extending between a proximal end and a distal end and defining a central lumen having a longitudinal axis, wherein at least one of the proximal and distal ends is open. wherein the cylindrical tube includes at least one opening extending across the side wall from the interior surface to the exterior surface; and
at least one pod configured and sized for insertion into the at least one opening and for detachable connection with the cylindrical tube, wherein the at least one pod includes a cap and A simulated tissue portion connected to a cap, the cap comprising a frame having a flange and defining an opening, the simulated tissue portion comprising at least one planar layer of silicone having an inner surface and an outer surface. wherein the simulated tissue portion is connected to the flange such that the outer surface of the simulated tissue portion is connected to the flange and the simulated tissue portion spans an opening defined by the frame, and the pod. wherein the simulated tissue model is removably connectable to the cylindrical tube such that when connected to the cylindrical tube, the simulated tissue portion is aligned with the interior surface of the side wall.
In claim 1,
The frame is substantially cylindrical in shape with the opening at a proximal end and a closed distal end, and the flange is substantially perpendicular to a side wall of the frame and extends radially outward from the proximal end.
In claim 2,
wherein the flange is located at the proximal end of the frame and at least partially surrounds the opening.
In claim 1,
The flange includes a flange surface configured to connect to and suspend the at least one planar layer of silicone, the flange surface being contoured to match a portion of the interior surface of the cylindrical tube in which the flange surface is received. ,Simulated organization model.
In claim 4,
The at least one flat layer of silicone is connected to the flange surface such that a central portion of the at least one flat layer of silicone is free to bend in response to impact by surgical instruments, and A simulated tissue model, wherein the central portion is suspended in a trampoline manner.
In claim 1,
A simulated tissue model, wherein the frame defines a circular opening, and the simulated tissue portion covers the circular opening.
In claim 1,
The frame includes opposingly disposed depressible detents for insertion and removal of the cap relative to the cylindrical tube, the opposedly disposed detents allowing the at least one pod to move the simulated tissue. A simulated tissue model that is configured to bend inward and spring back outward when attached to and detached from the model.
In claim 1,
The simulated tissue portion further comprises a simulated tumor, the simulated tumor comprising at least one flat layer of silicone such that the simulated tumor faces an interior space of the simulated tissue model and protrudes toward the longitudinal axis. A simulated tissue model connected to the inner surface of.
In claim 8,
The simulated tissue model of claim 1, wherein the simulated tissue portion and the interior surface of the cylindrical tube are pink or red while the simulated tumor has a contrasting dark red, brown or black color.
In claim 1,
The simulated tissue portion includes a protrusion extending from the interior surface of the at least one planar layer of silicone, wherein the simulated tissue portion and the interior surface of the cylindrical tube are pink or red while the protrusion is a contrasting color. A simulated tissue model with a dark red, brown or black color.
In claim 1,
A simulated tissue model, wherein the simulated tissue portion includes a first layer of silicone and a second layer of silicone.
In claim 11,
The first layer of silicone is a substantially flat layer having a first side and a second side, and the first layer of silicone is connected to the frame with the first side facing the interior space of the simulated tissue model. wherein the second layer of silicon is a substantially flat layer having a first side and a second side, and wherein the second layer of silicon is a substantially flat layer having a first side and a second side, and wherein the first side of the second layer is a substantially flat layer of the first layer. A simulated tissue model connected to the first layer of silicone so as to face and contact the side.
In claim 12,
The simulated tumor is a simulated tissue model attached to or integrally formed with the first layer of silicone such that the simulated tumor is connected to or extends outwardly from the first side of the first layer. .
In claim 13,
The first layer of silicone is configured such that at least a portion of the first layer of silicone adjacent to or beneath the simulated tumor is attached to the second layer of silicone to facilitate resection of the simulated tumor. A simulated tissue model that is selectively attached to the second layer of silicone so that it is not damaged.
In claim 14,
wherein the first layer of silicone is attached to the second layer of silicone only peripherally around the simulated tumor.
In claim 13,
The second layer of silicone is configured to provide visual feedback to facilitate ablation of the simulated tumor, the second layer of silicone is yellow, the first layer of silicone and the inner surface of the cylindrical tube. is pink or red while the simulated tumor has a contrasting dark red, brown or black color.
In claim 11,
The simulated tissue portion further includes a mesh layer embedded in the first layer of silicone, the second layer of silicone, or both, wherein remnant defects created in the first layer of silicone are sutured. A simulated tissue model that can be surgically closed with staples or staples.
In claim 1,
The interior surface of the side wall includes a recess surrounding the at least one opening, the recess configured to receive the flange such that the simulated tissue portion is substantially flush with the interior surface of the side wall. A simulated organizational model that is sized and configured.
In claim 1,
The simulated tissue model of claim 1, wherein the cylindrical tube further includes transverse folds along the longitudinal axis.
In claim 1,
The at least one pod includes a plurality of tissue pods and the at least one opening includes a plurality of openings, the plurality of tissue pods configured to serve as tissue insertions filling the plurality of openings while the cylindrical shape A simulated tissue model, wherein the tube represents a portion of a simulated colon, rectum, or intestinal section, and the tissue inserts include at least one simulated tumor and/or at least one other surgical target.